a study of anlotinib in patients with hepatocellular carcinoma

Conditions: Hepatocellular Carcinoma

Summary: to assess the primary effects and safety of anlotinib with placebo in patients with hepatocellular carcinoma(hcc).


Eligibility criteria:
inclusion criteria: * conform to the clinical diagnosis standard strictly or histological or cytological confirmation of hepatocellular carcinoma who cannot benefit from treatments of ablative therapy * liver function status child-pugh class a or b (score≤8) * enroll 2 group patients：group a：no history of systematic chemotherapy/target therapy.group b:failed with sorafenib(last sorafenib therapy≥4 weeks ) * last therapy≥4 weeks (such as surgery, pci,ablation, radiotherapy)，and the wound healing.patients with adjuvant chemotherapy, last chemotherapy ≥6m * at least one measurable lesion (by recist1.1) * 18-75 years,ecog ps:0-1,life expectancy of more than 3 months * main organs function is normal * women of childbearing potential should agree to use and utilize an adequate method of contraception (such as intrauterine device，contraceptive and condom) throughout treatment and for at least 6 months after study is stopped；the result of serum or urine pregnancy test should be negative within 7 days prior to study enrollment，and the patients required to be non-lactating；man participants should agree to use and utilize an adequate method of contraception throughout treatment and for at least 6 months after study is stopped * patients should participate in the study voluntarily and sign informed consent exclusion criteria: * diagnosed with cholangiocellular carcinoma, mixed cell carcinoma and fibrolamellar hepatocellular carcinoma * history of other malignancy (except for non-melanoma skin cancer, cervix in situ carcinoma) * liver function status child-pugh class c (score\>9),with malignant ascites * hbv-dna\>2000iu/ml * history of liver transplantation or prepare for it * patients with any severe and/or unable to control diseases，including： 1. blood pressure unable to be controlled ideally(systolic pressure≥150 mmhg，diastolic pressure≥100 mmhg); 2. patients with grade 1 or higher myocardial ischemia, myocardial infarction or malignant arrhythmias(including qt≥480ms) and patients with grade 1 or higher congestive heart failure (nyha classification); 3. patients with active or unable to control serious infections; 4. patients with poorly controlled diabetes (fasting blood glucose(fbg)\>10mmol/l) 5. urine protein ≥ ++，and 24-hour urinary protein excretion\>1.0 g confirmed * patients with arterial or venous thromboembolic events occurred within 6 months, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism * patients with drug abuse history and unable to get rid of or patients with mental disorders * imaging showed tumors have involved important blood vessels or by investigators determine likely during the follow-up study and cause fatal hemorrhage * patients participated in other anticancer drug clinical trials within 4 weeks * history of immunodeficiency * patients with concomitant diseases which could seriously endanger their own safety or could affect completion of the study according to investigators' judgment

Keywords: anlotinib al3818